MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27; FLOW DIVERTER

Model Number	FREDX4515-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thirteen days post-implantation of a flow diverter in the carotid ophthalmic artery, the patient returned to the hospital exhibiting stroke symptoms.It was noted that the flow diverter was occluded with thrombus and the clot was retrieved using aspiration.Flow was restored and the patient is neurologically intact.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains implanted in the patient and is therefore not available for return to the manufacturer for analysis.Medical imaging was provided and the investigation is ongoing.The instructions for use (ifu) identifies stent thrombosis and stroke or tia (transient ischemic attack as a potential complication associated with use of the device.
Additional Manufacturer Narrative
Corrections: h6: component code: remove 4755; add: 515.Investigation findings: remove 3233; add: 213.Investigation conclusions: remove 11; add: 4315.Additional information: eight radiographic images were provided for review.Four 3d angios of the ica (probably right, image sides are not labeled): show a broad-based laterally pointing para-ophthalmic aneurysm.Measurements of the parent artery (in lateral projection) are 3.59 mm proximally, and 3.96 mm distally.The ica in between these two measurements is larger in diameter, but no measurements are available.One image shows measurements of the aneurysm in lateral projection: 5.00 mm x 3.4 mm.The adjacent ica measures about the same diameter as the aneurysm's longest diameter.One last measurement of the mid-ica siphon in caudo-cranial projection is provided: 5.25 mm.One native non-subtracted lateral image centered on the fred x post-deployment shows the fred x to be fully open.Two non-subtracted dsas with contrast of the left ica post-deployment in oblique lateral projections: one shows good wall apposition, with no contrast material beyond the helices.The other appears to show a small sliver of contrast material outside the helices, between the anterior wall of the distal genu of the ica and the helices, but it is difficult to say for sure, as there is superimposed bone, and no subtracted dsa is provided.One sim&cure image in lateral projection shows adequate apposition of the simulated fred.No images of the thrombectomy or post-thrombectomy procedure are provided.Without the return and physical evaluation of the device, the investigation cannot determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: FRED X27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14989121
• Report Number: 2032493-2022-00275
• Device Sequence Number: 1614415
• Product Code: OUT
• UDI-Device Identifier: 00842429114391
• UDI-Public: (01)00842429114391(11)210629(17)240531(10)0000146060
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: FREDX4515-PMA
• Device Catalogue Number: FREDX4515
• Device Lot Number: 0000146060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRILINTA/ASA ANTIPLATELET THERAPY (PRE & POST-OP)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female